3. Ethics Committee (EC)/Institutional Review Board (IRB)

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. 

As per Art 10 of the Act March 2023, documents required for submission are in accordance with the EU CTR 536/2014.

The EU Regulation 536/2014 specifies that the documents to be evaluated are divided into two sections:

• Part 1 (including protocol and investigator information, benefit-risk assessment; see Article 6)
• Part 2 (including requirements for consent; recruitment; suitability of the trial site as well as persons involved in the conduct; data protection; insurance; and handling of biomaterials; see Article 7)

Those are submitted via the CTIS portal (the EU’s Clinical Trials Information System):

3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.

The timelines are set out in the table below, based on Art 5 (Application), Art 6 (Assessment report – aspects covered by Part I) & Art 7 (Assessment report – aspects covered by Part II), of the EU CTR 536/2014:

• In red: Time for sponsor to respond to questions (RFIs).
• In green: Time for RMS or MSC to assess and discuss responses.
• RMS: Reporting Member State
• MSC: Member State Concerned

If the response to the RFI is not submitted within the timeframe provided, the application will lapse.

3.3 Does EC/IRB have any fast-track or expedited review process?

No, not that we have been able to determine.

3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?

Yes – see Articles 18 and 21 of the Act March 2023, which set out the mechanism and criteria used.

“Article 18

(1) The Chairman of the Supreme Bioethics Commission shall maintain a list of bioethics commissions.

(2) Entry in the list of bioethics committees shall be made at the request of the bioethics committee referred to in Article 19.

(3) The bioethics committee referred to in Article 19 shall submit an application for entry into the list of bioethics committees together with the rules of procedure of the bioethics committee referred to in Article 19, documents confirming the professional qualifications and education of the members of the bioethics committee, and documents confirming the possession and proper security of the IT infrastructure ensuring the proper circulation of documents, in accordance with the provisions of Regulation 536/2014.”

And:

“Article 21

(1) The ethical evaluation of a clinical trial under the rules set forth in this Chapter shall be prepared by:

1) the Supreme Bioethics Commission or,

2) a bioethics committee designated by the Chairman of the Supreme Bioethics Committee and included in the list of bioethics committees, hereinafter referred to as the "designated bioethics committee".

(2) The chairman of the Supreme Bioethics Commission, when appointing a bioethics committee to prepare an ethical evaluation of a clinical trial from the list of bioethics committees, shall take into account:

1) the experience of the bioethics committee in preparing the ethical evaluation of clinical trials in the field of medicine and the study population specific to the clinical trial for which the evaluation is to be prepared;

2) the possibility of timely preparation of the ethical evaluation of the clinical trial.

(3) When designating a bioethics committee from the list of bioethics committees, the chairman of the Supreme Bioethics Committee shall grant access to the designated bioethics committee to the content of the application that is the subject of the ethical evaluation of the clinical trial and shall make the clinical trial documentation available on the EU portal.”

3.5 How frequently do EC/IRB meet?

Polish Bioethical committees authorized to review studies submitted under the EU CTR 536/2014 will meet as required to fulfill their obligations within the review timelines established in the EU CTR.

3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

No, not that we are aware of.

3.7 Please describe the process of the EC/IRB submission for clinical trial approval.

The Clinical Trial application is submitted to the EMA CTIS portal; no separate application is required to be made to the Ethics Committee. 

EMA provides detailed training modules to help use the Clinical Trial Information System (CTIS).

3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)?

Art 58 (1) of the Act of March 2023 deals with the fees payable. Fees apply to initial clinical trial applications and substantial amendments.

The fees vary between approximately USD5-7,000, depending on whether the clinical trial is Phase I-IV, and have to be divided between and paid into two separate bank accounts – one for the Medical Research Agency (Supreme Bioethics Committee) and one to URPL/the Office (see also sections 4.7 and 4.8 of this guidebook) as follows:

“A fee shall be payable, insofar as the implementation of the provisions of EU CTR 536/2014 is concerned, for the submission of an application for a permit:

1) a commercial clinical trial of phases I-III, where the Republic of Poland acts as rapporteur;

2) commercial clinical trial of phase I-III, where the Republic of Poland does not act as rapporteur;

3) a commercial phase I-III clinical trial under Article 14 of Regulation 536/2014;

4) a phase IV clinical trial, where the Republic of Poland acts as rapporteur…”.

Art 58(2) provides that:

“[t]he fee shall be:

1) PLN 30,000 [approximately USD7,000 at current rates] for submission of the application referred to in paragraph 1 item 1, of which PLN 15,000 [approximately USD3,500 at current rates] shall be paid to the Agency’s bank account and the remaining amount to the Authority’s bank account;

2) PLN 25,000 [approximately USD5,750 at current rates] for submitting the application referred to in paragraph 1 items 2, 3, and 4, of which PLN 15,000 [approximately USD3,500 at current rates] shall be paid to the Agency’s bank account and the remaining amount to the Authority’s bank account;

3) PLN 21,000 [approximately USD4,850 at current rates] for submitting the application referred to in paragraph 1 points 5 and 6, of which PLN 15,000 [approximately USD3,500 at current rates] shall be paid to the Agency’s bank account and the remaining amount to the Authority’s bank account…”.

(Art 15 (1) of the Act of March 2023, provides that “[t]he Supreme Bioethics Commission shall operate at the Medical Research Agency, hereinafter referred to as the “Agency”, whilst the “Authority” is understood to be URPL/the Office (see Chapter 5 of the Act) and not the Supreme Bioethics Commission).

3.9 Does EC/IRB accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

All payments can be made electronically.

For payments to the Bioethics Committee, please consult the website directly, where you can find fees depending on the level of service provided as well as the bank account details.

3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

Yes, EMA has created very comprehensive guidance, presentations, and videos to aid Sponsors and organizations in understanding the EU CTR requirements and navigation of the CTIS portal. 

Relevant EMA guidance and training modules can be found here.

Additionally, the Medical Research Agency has published training material (only in Polish) which provides additional information on the requirements for submission under the EU CTR 536/2014.

The Clinical Trial application is submitted to the EMA CTIS portal. This is the only application that needs to be made in terms of the EU CTR 536/2014.

Sponsors wishing to use CTIS must have an EMA account. Users who do not have an EMA account can register through the EMA Account Management facility.

Organizations may need to go through additional registration steps based on the user management approach that was used for CTIS. The organization-centered approach enables user management by an administrator at the organization level, rather than at the level of an individual trial. This is intended for organizations that run various trials through CTIS. To make use of this organization-based approach, organizations must ensure that they are registered in the EMA Organization Management System (OMS) and must register a CTIS High-Level Administrator through the EMA Account Management webpage. 

Below are some guidance and training modules made available by EMA:

1. Getting started with CTIS – Sponsor Quickguide
2. CTIS Sponsor handbook
3. Reference Materials for Clinical Trial Sponsors

3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

The position is that whilst patient materials such as informed consent forms, patient information leaflets, and participant-facing recruitment material are required to be submitted under the CTR, materials used post-consenting (patient cards, questionnaires, diaries) are not.

See question 1.24 of the EMA EU CTR - Questions & Answers (the most up-to-date version can be found in Eudralex Volume 10).

Subject Information, Informed Consent, and Informed Consent Procedure be provided in Polish.

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

Yes, updated templates for Informed Consent Forms (ICF) for Adults and Minor participants can be found on the Medical Research Agency webpage.

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

Yes. For insurance requirements, please refer to section 2.18 of this guidebook.

In Poland, there is a Clinical Trials Compensation Fund which was established to pay compensation benefits in the event of body injury or health impairment as a result of participation in a clinical trial. More information can be found under Chapter 7 of the Polish Act of March 2023.

3.14 Are there any specific local safety reporting requirements for clinical studies?

For studies submitted in accordance with the provisions of EU CTR 536/2014 and therefore via the CTIS portal, annual patient safety reports and reports of unexpected serious adverse reactions to medicinal products must be submitted in accordance with that Regulation (i.e. Annual Participant Safety Reports (ASRs) to the ASR EudraVigilance Module on the CTIS Portal and reports of Unexpected Serious Adverse Reactions (SUSARs) directly to the EudraVigilance Clinical Trial Module). 

With regards to studies carried out in accordance with Regulation 536/2014, it is not required to submit safety reports directly to the Bioethics Committee.

3.15 Does the EC/IRB require any periodic study reporting?

No, annual safety reporting and other required notifications are submitted via the EMA CTIS portal.